Ex parte WANG et al.

Board of Patent Appeals and Interferences

Jul 30, 1999

07521695 (B.P.A.I. Jul. 30, 1999)

Application for patent filed May 15, 1990.1
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for
publication in a law journal and (2) is not binding precedent of the Board.
Paper No. 25
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte BOSCO S. WANG, ARACELI L. LUMANGLAS,
and IAN C. HART
__________
Appeal No. 95-3268
Application 07/521,6951
___________
ON BRIEF
___________
Before WINTERS, WILLIAM F. SMITH and ROBINSON, Administrative Patent Judges.
ROBINSON, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 from the examiner's final
rejection of claims 5 - 32, all of the claims pending in the application. Claims 5 and 23 are
illustrative of the claims on appeal and are appended to this decision.
Appeal No. 95-3268
Application 07/521,695
In view of our affirmance of the rejection of claims 23-25 under 35 U.S.C. § 102(b),2
the rejection of these claims under 35 U.S.C. § 103, over the same references, is rendered
moot.
2
The references relied upon by the examiner are:
Aston et al. (Aston I) EP 137,234 Apr.17, 1985
Guyton, Textbook of Medical Physiology, pub. W.B. Saunders Co., pages 919-923,
(1981).
Aston (Aston II), Molecular Immunology, 24(2), pages 143-150, (1987).
Grounds of Rejection
Claims 23 - 25 stand rejected under 35 U.S.C. § 102. As evidence of anticipation,
the examiner relies upon Aston (I) and Guyton.
Claims 5 - 32 stand rejected under 35 U.S.C. § 103. As evidence of obviousness,
the examiner relies upon Aston (I) and Guyton.
Claims 5 - 22 and 26 - 32 stand rejected under 35 U.S.C. § 103. As evidence of
obviousness, the examiner relies upon Aston (I), Guyton, and Aston (II).
We affirm the rejection of claims 23-25 under 35 U.S.C. § 102 and the rejection of
claims 26, 31, and 32 under 35 U.S.C. § 103 and reverse the rejection of claims 5-22 and
27-30 under 35 U.S.C. § 103.2
Appeal No. 95-3268
Application 07/521,695
3
Background
The applicants' invention, as presently claimed, is described at page 2 of the
specification as being directed to a method of enhancing animal growth by treating
vertebrates with a combination of one or more antibodies to porcine somatotropin with
porcine somatotropin. Additionally, at page 3 of the specification, applicants describe the
other aspect of their invention as relating to potentiation of the activity of a somatotropin
over prolonged periods of time by administering, to a vertebrate, a somatotropin in
combination with one or more antibodies to said somatotropin, such that the weight of the
vertebrate continues to exceed that of a vertebrate treated with the same amount of the
somatotropin alone over a given period of time.
Discussion:
The rejection under 35 U.S.C. § 102(b)
Claims 23-25 stand rejected under 35 U.S.C. § 102(b) as anticipated by Aston(I) as
evidenced by Guyton.
Guyton is relied upon, by the examiner, only to establish that the term
"somatotropin" is synonymous with the phrase "growth hormone" (Answer, page 6), a fact
conceded by appellants (principal brief, page 8). We therefore view these terms as
interchangeable in our discussion of the issues in this appeal. Thus, the sole issue before
us under this ground of rejection, is whether Aston (I) anticipates the subject matter of
claims 23-25.
Appeal No. 95-3268
Application 07/521,695
4
Anticipation requires the disclosure, in a single prior art reference, of each element
of the claim under consideration. W.L. Gore & Assoc. v.Garlock, Inc., 721 F.2d 1540,
1554, 220 USPQ 303, 313 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984). In
considering Aston (I), we note particularly Example A, which discloses the administration
of a human growth hormone and antibody combination to non-human vertebrate. The
observed results, over a period of three weeks, included increased weight gain in the thus
treated mice as compared to the control given no growth hormone or given growth
hormone without the antibody. This example would reasonably appear to meet all
limitations of claim 23 and establish a prima facie case of anticipation of the claimed
subject matter with regard to claims 23-25.
In rebuttal, appellants argue that the reference fails to disclose the limitations of
claim 23, which require "potentiating the activity of a somatotropin over prolonged periods
of time" and "such that the weight of the vertebrate [, non-human] continues to exceed that
of a vertebrate [, non-human] treated with the same amount of said somatotropin alone
over a given period of time." (reply brief, page 3). Where functional language is used, it is
appropriate to look to the specification for guidance in determining the finite amounts
which correspond to the functional language. See In re Woodruff, 919 F.2d 1575, 1577,
16 USPQ2d 1934, 1936 (Fed. Cir. 1990); In re Herz, 537 F.2d 549, 551, 190 USPQ 461,
463 (CCPA 1976). We find nothing in the specification which would define or limit this
Appeal No. 95-3268
Application 07/521,695
5
cited functional claim language. Additionally, we find nothing which would reasonably
suggest that the 21 day period of Example A of Aston (I) would not be regarded as a
"prolonged period of time." The reference does not teach that the observed effect on
weight gain ended after the 21 days, only that the test data was recorded only for that
specified time period. Similarly, there is nothing in the specification which would indicate
that the observed weight gain in the mice of Example A of Aston (I) treated with the growth
hormone and antibody combination as compared to that of growth hormone alone, would
not meet the requirement that "the weight of the vertebrate, non-human continues to
exceed that of a vertebrate, non-human treated with the same amount of said somatotropin
alone over a given period of time" as required by the claim 23. Where the Patent Office
has reason to believe that a functional limitation asserted to be critical for establishing
novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior
art, it possesses the authority to require the applicant to prove that the subject matter
shown in the art does not possess the characteristic relied on. This burden is applicable to
product and process claims reasonably considered as possessing the allegedly inherent
characteristics. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) and
In re Swinehart, 439 F.2d 210, 212-213, 169 USPQ 226, 228- 229 (CCPA 1971). On the
record before us, the appellants have offered no evidence which would demonstrate that
the method disclosed Aston (I) would not result in the functionally defined results of
Appeal No. 95-3268
Application 07/521,695
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"potentiating the activity of a somatotropin over prolonged periods of time" and "such that
the weight of the vertebrate, non-human continues to exceed that of a vertebrate, non-
human treated with the same amount of said somatotropin alone over a given period of
time" as claimed.
We find no error in the examiner's findings that Aston (I) taken with Guyton establish
a prima facie case of unpatentability of the subject matter of claims 23-25. We, therefore,
affirm the rejection of claims 23-25 under 35 U.S.C. § 102(b).
The rejections under 35 U.S.C. § 103
Claims 5-22 and 27-30:
A conclusion of obviousness under 35 U.S.C. § 103 must be based upon the
claimed subject matter as a whole. Accordingly, before turning to the merits of the
examiner's rejection, we must first determine what subject matter is claimed.
We read claims 5-22 and 27-30 to require, in relevant part, the administration of a
somatotropin and one or more monoclonal antibodies obtained from the deposited
hybridomas designated as PS-7.6 (ATCC HB 10416), PS-3.12 (ATCC HB 10415) and
PS-8.3 (ATCC HB 10417); no more and no less. The examiner has offered no evidence
or put forth no facts relating to the use of these specified monoclonal antibodies. It is the
initial burden of the patent examiner to establish that claims presented in an application for
patent are unpatentable. In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d 1443, 1445
Appeal No. 95-3268
Application 07/521,695
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(Fed. Cir. 1992). The examiner's rejection of these claims is fatally defective since they do
not properly account for and establish the obviousness of the subject matter as a whole.
Where, as here, the examiner fails to establish a prima facie case, the rejection is
improper and will be overturned. In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598
(Fed. Cir.1988). We conclude that, with regard to claims 5-22 and 27-30, the examiner
has failed to establish a prima facie case of obviousness. We, therefore, reverse the
rejection of claims 5-22 and 27-30 under 35 U.S.C. § 103.
Claims 26, 31 and 32:
Claims 26, 31, and 32 stand rejected under 35 U.S.C. § 103 as being obvious over
Aston (I) in view of Guyton and as obvious over Aston (I) in view of Guyton and Aston (II).
We elect to treat these two grounds of rejection together, since the rejection over Aston (I)
and Guyton is subsumed by the rejection over Aston (I), Guyton, and Aston (II).
As noted above, it is the initial burden of the patent examiner to establish that
claims presented in an application for patent are unpatentable. In re Oetiker, supra. On
the record before us, we agree that Aston (I) generically discloses the potentiating of the
hormonal activity of growth hormones by administering, to non-human vertebrate, a growth
hormone with at least one antibody which binds to that hormone in order to obtain an
increase in cumulative weight gain in the vertebrate. In addition, Aston (II), which
discloses porcine somatotropin as a growth hormone, would have suggested to those of
Appeal No. 95-3268
Application 07/521,695
8
ordinary skill in this art to substitute porcine somatotropin and its antibodies for the growth
hormone and antibodies of Aston (I). Where, as here, a prima facie case of obviousness
has been established, the burden of going forward shifts to the appellants. In re Piasecki,
745 F.2d 1468, 1472, 223 USPQ 785, 788 (Fed. Cir. 1984), In re Rinehart, 531 F.2d
1048, 1052, 189 USPQ 143, 147, (CCPA 1976).
The appellants have offered no arguments or evidence to indicate that one of
ordinary skill in this art would have expected any difference in results in the methodology of
Aston (I) if porcine somatotropin were substituted for the human growth hormone
specifically disclosed.
In rebuttal, appellants' urge (principal brief, pages 20 and 21) that Aston (I) does not
teach:
the novel concept that administration of an antibody to a somatotropin
together with that somatotropin potentiates the activity of the somatotropin
over prolonged periods of time, such that the weight of the vertebrate
continues to exceed that of a vertebrate treated with the same amount of the
somatotropin alone.
However, as we pointed out in our consideration of the rejection of claims 23-25
under 35 U.S.C. § 102(b), supra, this functional language is not defined in the specification
and does not serve to distinguish the claimed subject matter from the disclosure of Aston
(I).
To the extent that appellants have attempted to compare the claimed method with
that of Aston (I) (principal brief, pages 9-16 and 21-22), we note that there are no side-by-
Appeal No. 95-3268
Application 07/521,695
9
side comparisons. In comparing the evidence of the specification with the evidence
presented in Aston (I), appellants attempt to compare results where the test animals differ,
the regimens of administration differ, and where the dosages differ. We find that we agree
with the examiner's determination (Answer, pages 14-15) that appellants have provided no
relevant evidence which establishes the alleged unexpected results. It is well settled that
the burden of establishing the significance of data in the record, with respect to
unexpected results or for other purposes, rests with appellants, which burden is not carried
by mere arguments of counsel. See generally In re Geisler, 116 F.3d 1465, 1470, 43
USPQ2d 1362, 1365-66 (Fed. Cir. 1997); In re Huang, 100 F.3d 135, 140, 40 USPQ2d
1685, 1689-90 (Fed. Cir. 1996); In re Merck & Co., Inc., 800 F.2d 1091, 1099, 231 USPQ
375, 381 (Fed. Cir. 1986).
To the extent that appellants may allege criticality with regard to the number of days
of administration, the dosage amounts, percentage weight gain, number of injections, or
appellants' 56 day study, we note simply that there are no claim limitations directed to
these parameters and therefore they do not serve to distinguish the claimed subject matter
from the disclosure of the cited references.
On the record before us, we find that the examiner has established a prima facie
case of unpatentability of the claimed method. Appellants have failed to overcome the
prima facie case against patentability, either by arguments or evidence. Therefore, the
Appeal No. 95-3268
Application 07/521,695
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rejection of claims 26, 31, and 32 under 35 U.S.C. § 103 is affirmed.
SUMMARY
To summarize, the decision of the examiner to reject claims 23-25 under 35 U.S.C.
§ 102 is affirmed. The decision of the examiner to reject claims 26, 31 and 32, under 35
U.S.C. § 103 is affirmed. The decision of the examiner to reject claims 5-22 and 27-30 is
reversed.
No time period for taking any subsequent action in connection with this appeal may
be extended under 37 CFR § 1.136(a).
AFFIRMED-IN-PART
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
WILLIAM F. SMITH ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
DOUGLAS W. ROBINSON )
Administrative Patent Judge )
Appeal No. 95-3268
Application 07/521,695
11
AMERICAN CYANAMID COMPANY
PATENT LAW DEPARTMENT
ONE CYANAMID PLAZA
WAYNE, NJ 07470-8426
Appeal No. 95-3268
Application 07/521,695
1
APPENDIX
5. A method for potentiating the activity of pST which comprises administering
to a vertebrate, non-human an effective growth enhancing amount of pST and an effective
pST-potentiating amount of one or more monoclonal antibodies which specifically bind
pST or an antigenic equivalent of pST, wherein the monoclonal antibodies are selected
from the group consisting of monoclonal antibodies designated PS-7.6 (ATCC HB
10416), PS-3.12 (ATCC HB 10415) and PS-8.3 (ATCC HB 10417).
23. A method for potentiating the activity of a somatotropin over prolonged
periods of time which comprises administering to a vertebrate, non-human an effective
growth enhancing amount of a somatotropin and an effective somatotropin-potentiating
amount of one or more antibodies which specifically bind said somatotropin or an
antigenic equivalent of said somatotropin, such that the weight of the vertebrate non-human
continues to exceed that of a vertebrate, non-human treated with the same amount of said
somatotropin alone over a given period of time.